Drug Development

On Forbes.com, the drug
industry analyst Avik Roy has written a comment on my piece "The Treatment" in last week's New Yorker.A few small
points, in response.

Roy is of the impression
that that I believe we should abandon rational drug design and, as he puts it,
“go back to the old way of doing things: of throwing mud on a wall and seeing
what sticks.”

I’m not sure where he
gets that idea. “The Treatment” makes it clear that both strategies—rational drug design and
mass screening--have a place in drug development. When the biology of a disease is well
understood (as in the case of Herceptin and breast cancer) then the former
strategy makes sense. But in those cases where it is not, then there is much to
be said for following a more serendipitous path. I suspect that most drug development experts would agree with me on this. In fact,
it’s probably the case—contra Roy--that one of the most compelling criticisms
of the drug industry at the moment is that it has gone too far in the rational
direction. In a piece in the December “Nature Reviews,” for example, Bernard
Munos writes:

Success in the pharmaceutical
industry depends on the random occurrence of a few ‘black swan’ products.
Common processes that are
standard practice in most companies create little value in an industry
dominated by blockbusters. These include developing sales forecasts for new products,
which are inaccurate nearly 80% of the time. Another example is portfolio
management, which has ebeen
widely adopted by the industry as a risk management tool, but has failed to
protect it from patent cliffs. During the past couple of decades, there has
been a methodical attempt to codify every facet of the drug business into
sophisticated processes, in an effort to reduce the variances and increase the
predictability. This has produced a false sense of control over all aspects of
the pharmaceutical enterprise, including innovation.

I got the impression from from Roy’s piece
that he was trying very hard to disagree with me. (Calling his post "Malcolm Gladwell is Wrong," was one clue). I’m not sure the effort
was successful. He points out, for example, that some doubted Synta’s promising
phase two data, in the belief that they were an artifact of the trial design:
that there were differences in the health status of the control and treatment arms of the
study. A good portion of my piece, of course, is devoted to the same general argument.
What interested me was in describing the complications and difficulties
and in many cases unavoidable issues in trial design that can make a drug look far more promising
in early clinical testing than it actually is.

Roy goes on:

One gets the impression that Gladwell followed elesclomol over the
years in the hopes of using its story for one of his books: the story of how
luck and intuition can lead to pharmaceutical success. But the opposite
happened, and the account ended up inThe
New Yorker instead. In Gladwell's final assessment, the story remained one
about luck: but about bad luck instead of good

I do hope my editors at the New Yorker don’t read that and think
that I give them my leftovers! And I wish it were the case that I knew what my next book was all about! The truth is that "The Treatment" was always a New Yorker piece. And I had no preconceptions about
how the Synta story might end when I began reporting it, except that I guessed
that would be a good case study in the many difficulties of coming up with
new cancer drugs. Unfortunately for the many thousands of melanoma patients
around the world, it was.

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Bio

I'm a writer for the New Yorker magazine, and the author of four books, "The Tipping Point: How Little Things Make a Big Difference", "Blink: The Power of Thinking Without Thinking" and "Outliers: The Story of Success." My latest book, "What the Dog Saw" is a compilation of stories published in The New Yorker. I was born in England, and raised in southwestern Ontario in Canada. Now I live in New York City.

My great claim to fame is that I'm from the town where they invented the BlackBerry. My family also believes (with some justification) that we are distantly related to Colin Powell. I invite you to look closely at the photograph above and draw your own conclusions.